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COMPLETEDPHASE1/PHASE2

Pharmacotherapy & CM for Opioid and Cocaine Dependence

NCT00838981•Yale University

Summary

The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence. To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.

Detailed Description

We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1. Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trial.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female opioid-dependent patients between the ages of 18-65 will be entered into the study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
•Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
•Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
•Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks prior to admission to the study is required.
•Subjects must be treatment-seekers for opioid and cocaine use.

Exclusion Criteria

•Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates, cocaine, or tobacco)
•History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
•History of severe renal, endocrine or hepatic diseases.
•History of psychosis, schizophrenia, or bipolar type I.
•History of seizure disorder.
•Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
•Liver function tests (SGOT,SGPT) greater than 3 times normal.
•Current use of modafinil
•Current suicidality
•Pregnancy or breast-feeding;
+3 more criteria

Locations (1)

Department of Veterans Affairs

West Haven, Connecticut, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2014

Last Updated

December 3, 2021

Enrollment

ACTUAL participants

Conditions

Cocaine Dependence

Interventions

Modafinil

DRUG

Sugar Pill

DRUG

Contingency Management

BEHAVIORAL

Methadone

DRUG

cognitive behavioral treatment

BEHAVIORAL

Voucher Control

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacotherapy & CM for Opioid and Cocaine Dependence

Inclusion Criteria

Exclusion Criteria

Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals

Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction

Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

rTMS for Stimulant Use Disorders

Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence